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Comparative Study of NXL103 Versus Comparator in Adults With Community Acquired Pneumonia

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ClinicalTrials.gov Identifier: NCT00653172
Recruitment Status : Completed
First Posted : April 4, 2008
Last Update Posted : January 9, 2009
Information provided by:
Novexel Inc

Brief Summary:
The purpose of this study is to compare the efficacy, safety and tolerance of 2 different dose levels of oral NXL103 with oral comparator in the treatment of community acquired pneumonia in adults

Condition or disease Intervention/treatment Phase
Community Acquired Pneumonia Drug: NXL103 Drug: comparator Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 302 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Multicenter, Randomized, Double Dummy, Three-Arm Parallel-Group Comparative Study of the Efficacy, Safety and Tolerance of Oral NXL 103 Versus Oral Comparator in the Treatment of Community-Acquired Pneumonia in Adults
Study Start Date : October 2007
Primary Completion Date : June 2008
Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Drug: NXL103
500mg orally twice daily
Active Comparator: 3 Drug: comparator
comparator twice daily
Experimental: 2
Drug: NXL103
600mg orally twice daily

Primary Outcome Measures :
  1. Evaluate Clinical outcome [ Time Frame: early follow up visit (day 14 to 21) ]

Secondary Outcome Measures :
  1. Evaluate bacteriological outcome [ Time Frame: early follow up visit (day 14 to 21) ]
  2. Evaluate safety [ Time Frame: first dose, throughout treatment, and to follow up visit ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Community acquired pneumonia

Exclusion Criteria:

  • severe CAP
  • respiratory infections attributed to sources other than community acquired bacterial infection
  • concomitant pulmonary disease
  • history of hypersensitivity to study medication, macrolide or beta lactam antibiotics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00653172

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Sponsors and Collaborators
Novexel Inc

Responsible Party: Dr. Carole A. Sable Chief Medical Officer, Novexel SA
ClinicalTrials.gov Identifier: NCT00653172     History of Changes
Other Study ID Numbers: NXL103/2001
First Posted: April 4, 2008    Key Record Dates
Last Update Posted: January 9, 2009
Last Verified: January 2009

Keywords provided by Novexel Inc:
community acquired pneumonia

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Streptogramin A
Anti-Bacterial Agents
Anti-Infective Agents